Phase 1 Trials in Pancreatic Cancer

  • Esther Yu Department of Radiation Oncology, Tufts Medical Center. Boston, MA, USA
  • Muhammad Wasif Saif Departments of Radiation Oncology and Medical Oncology, Tufts Medical Center. Boston, MA, USA
  • Kathryn Huber Department of Radiation Oncology, Tufts Medical Center. Boston, MA, USA
Keywords: Clinical Trials, Phase I as Topic, Drug Therapy, Pancreatic Neoplasms, Radioimmunotherapy


Despite many clinical trials over the last two decades since the approval of gemcitabine, the survival of patients with pancreatic cancer has improved by a few only months. This disappointing reality underlines an urgent need to develop more effective drugs or better combinations. A variety of phase I trials were presented at the annual meeting of ASCO 2014 focusing on locally advanced and metastatic pancreatic cancer. We summarize four abstracts (abstracts #4116, #4123, #4026, #4138).

Image: Radiation Oncology, Tufts Medical Center. Boston, MA, USA.


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Siegel R, Naishadham D, Jemal A. Cancer statistics. CA Cancer J Clin. 2012; 62(1): 10-29. [PMID:22237781]

Geer RJ, Brennan MF. Prognostic indicators for survival after resection of pancreatic adenocarcinoma. Am J Surg. 1993; 165(1): 68-72; discussion 72-3. [PMID:8380315]

Conroy T, Desseigne F, Ychou M, Bouché O, Guimbaud R, Bécouarn Y, Adenis A, et al., FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011; 364(19): 1817-25. [PMID:21561347]

Safran H, Charpentier K, Perez K, Mantripragada K, Austin TC, Nadeem O, Lombardo A, et al. Nab-paclitaxel (nab-P) combined with FOLFOX for advanced pancreatic cancer: A phase I study. J Clin Oncol., 2014; 32:5s (suppl; abstr 4123).

Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, Seayet T, et al. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013; 369(18): 1691-703.

Reid MD, Saka B, Balci S, Goldblum AS, Adsay NV. Molecular genetics of pancreatic neoplasms and their morphologic correlates: an update on recent advances and potential diagnostic applications. Am J Clin Pathol. 2014; 141(2): 168-80. [PMID:24436263]

Du X, Zhao YP, Zhang TP, Zhou L, Chen G, Wang TX, You L, et al., Alteration of the intrinsic apoptosis pathway is involved in Notch-induced chemoresistance to gemcitabine in pancreatic cancer. Arch Med Res. 2014; 45(1): 15-20. [PMID:24316112]

Vaccaro V, Melisi D, Bria E, Cuppone F, Ciuffreda L, Pino MS, Gelibter A, et al., Emerging pathways and future targets for the molecular therapy of pancreatic cancer. Expert Opin Ther Targets. 2011; 15(10): 1183-96. [PMID:21819318]

Wang Z, Li Y, Kong D, Banerjee S, Ahmad A, Azmi AS, Ali S, et al. Acquisition of epithelial-mesenchymal transition phenotype of gemcitabine-resistant pancreatic cancer cells is linked with activation of the notch signaling pathway. Cancer Res. 2009; 69(6): 2400-7. [PMID:19276344]

Cook N, Basu B, Smith DM, Gopinathan A, Evans TJ, Steward WP, Hagemannet T, et al. A phase I trial of the γ-secretase inhibitor (GSI) MK-0752 in combination with gemcitabine in patients with pancreatic ductal adenocarcinoma (PDAC). J Clin Oncol. 2014; 32:5s (suppl; abstr 4116).

Aikawa T, Gunn J, Spong SM, Klaus SJ, Korc M, et al., Connective tissue growth factor-specific antibody attenuates tumor growth, metastasis, and angiogenesis in an orthotopic mouse model of pancreatic cancer. Mol Cancer Ther. 2006; 5(5): 1108-16. [PMID:16731742]

Picozzi,VJ, Pipas JM, Koong A, Giaccia A, Bahary N, Krishnamurthi SS, Lopez CD, et al. FG-3019, a human monoclonal antibody to connective tissue growth factor (CTGF), with gemcitabine/erlotinib (G/E) in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC). J Clin Oncol. 2014; 32:5s (suppl; abstr 4138).

Gulec SA, Cohen SJ, Pennington KL, Zuckier LS, Hauke RJ, Horne H, Wegener WA, et al., Treatment of advanced pancreatic carcinoma with 90Y-Clivatuzumab Tetraxetan: a phase I single-dose escalation trial. Clin Cancer Res. 2011; 17(12): 4091-100. [PMID:21527562]

Ocean AJ, Pennington KL, Guarino MJ, Sheikh A, Bekaii-Saab T, Serafini AN, Lee D, et al. Fractionated radioimmunotherapy with (90) Y-clivatuzumab tetraxetan and low-dose gemcitabine is active in advanced pancreatic cancer: A phase 1 trial. Cancer. 2012; 118(22): 5497-506.

Picozzi VJ, Ramanathan RK, Lowery MA, Ocean AJ, Mitchell EP, O'Neil BH, Guarino MJ, et al. Feasibility and results of a randomized phase Ιb study of fractionated 90Υ-clivatuzumab tetraxetan in patients with metastatic pancreatic cancer having two or more prior therapies. J Clin Oncol. 2014; 32: 5s (suppl; abstr 4026).

Radiation Oncology, Tufts Medical Center. Boston, MA, USA
How to Cite
YuE., SaifM., & HuberK. (2014). Phase 1 Trials in Pancreatic Cancer. JOP. Journal of the Pancreas, 15(4), 326-328.
Highlights from the “50th ASCO Annual Meeting 2014”. Chicago, IL, USA. May 30 - June 3, 2014